Orange Book product · Brand (NDA)
FENTORA
FENTANYL CITRATE
At a glance
Sep 25, 2006
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 25, 2006
20 yr ago
Today
Patent 7862832 expires
Listed drug product patent expiration.
Jun 15, 2028
in 2 yr
Patent 7862833 expires
Listed drug product patent expiration.
Jun 15, 2028
in 2 yr
Pharmaceutical detail
Active ingredient
FENTANYL CITRATE
Strength
EQ 0.1MG BASE
Dosage form
TABLET
Route
BUCCAL, SUBLINGUAL
TE code
Not listed
Application
NDA 021947
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2023FENTANYL CITRATEBrand (NDA)
NDA 215870 · EXELA PHARMA
- 2023FENTANYL CITRATEBrand (NDA)
NDA 019101 · HIKMA
- 2011LAZANDABrand (NDA)
NDA 022569 · BTCP PHARMA
- 2011ABSTRALBrand (NDA)
NDA 022510 · SENTYNL THERAPS INC
- 2009ONSOLISBrand (NDA)
NDA 022266 · ADALVO
- 1998ACTIQBrand (NDA)
NDA 020747 · CEPHALON
- 1995FENTANYLBrand (NDA)
NDA 020195 · CEPHALON
- 1985FENTANYL CITRATEBrand (NDA)
NDA 019115 · HOSPIRA
- —SUBLIMAZE PRESERVATIVE FREEBrand (NDA)
NDA 016619 · RISING
- 2022FENTANYL CITRATEGeneric (ANDA)
ANDA 206329 · DR REDDYS LABS SA
- 2020FENTANYL CITRATEGeneric (ANDA)
ANDA 212086 · FRESENIUS KABI USA
- 2019FENTANYL CITRATE PRESERVATIVE FREEGeneric (ANDA)
ANDA 210762 · FRESENIUS KABI USA
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7862832 | Jun 15, 2028 | in 2 yr | Product |
| 7862833 | Jun 15, 2028 | in 2 yr | Product |
